This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
324
Drug: SHR-A1811 \& Pyrotinib SHR-A1811: intravenous Pyrotinib:oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811: intravenous SHR-1316: intravenous
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGDLT(Phase I (dose exploration phase) main study endpoint)
Time frame: 21 days after the first administration of each subject
AE(Phase I (dose exploration phase) main study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Time frame: Two years after the last subject was enrolled in the group
Toxin binding antibody to shr-a1811(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Objective Response Rate(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Duration of response(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
Progression Free Survival(Phase I secondary endpoint)
Time frame: Two years after the last subject was enrolled in the group
AE(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Toxin binding antibody to shr-a1811(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Duration of response(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Progression Free Survival(Phase II secondary study endpoint)
Time frame: Two years after the last subject was enrolled in the group
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